Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer

NCT00702481 | Completed Phase 2

• 1 other identifier: IB/NCCS-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to define the response and toxicities with the addition of Nimotuzumab to chemoradiation for head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Squamous Cell Cancer; Chemoradiation; EGFR monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• To determine the response rate of locally advanced HNSCC to treatment with Nimotuzumab and concurrent Cisplatin (CDDP) and Radiotherapy (RT).

  16 weeks

Secondary Outcomes (1)

• To assess the toxicities associated with this regimen

  16 weeks

Study Arms (1)

Nimotuzumab/CDDP/RT

EXPERIMENTAL

Open label treatment arm of Nimotuzumab and cisplatin and radiation

Drug: Nimotuzumab; Drug: Cisplatin; Radiation: Radiation

Interventions

Nimotuzumab DRUG

Patients will receive nimotuzumab 200 mg weekly for 8 weeks. Nimotuzumab will be started together with concurrent chemoradiation, and continued 1 week after the completion of chemoradiation.

Also known as: TheraCim-Rh3

Nimotuzumab/CDDP/RT

Cisplatin DRUG

Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.

Nimotuzumab/CDDP/RT

Radiation RADIATION

Concurrent radiotherapy will be given to the primary tumor and upper neck at 2 Gy per fraction, once a day, five days a week to a total of 70 Gy in 35 fractions in seven weeks.

Nimotuzumab/CDDP/RT

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck.
• Locally advanced disease, unresectable disease or resectable disease where organ-preservation is intended
• Age \> 18 years
• Adequate performance status of ECOG 0-2
• Life expectancy of at least 3 months
• Written informed consent to participate in the study
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
• Patients must have normal organ and marrow function as defined below:
• leukocytes \>3,000/uL
• absolute neutrophil count \>1,500/uL
• platelets \>100,000/uL
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) \< 2.5X normal . Creatinine within normal range and CCT(Cockcroft-Gault) \> 50 ml/min

You may not qualify if:

• Prior treatment with anti-EGFR or chemotherapy/radiotherapy
• Evidence of CNS metastases
• Poor performance status (ECOG 3-4)
• Evidence of severe or uncontrolled systemic disease (eg. unstable or uncompensated respiratory disorder, cardiac failure, hepatic decompensation, renal failure, nephritic syndrome, uncontrolled metabolic disorders such as diabetes mellitus, uncontrolled hypertension or uncontrolled significant infections)
• Pregnancy or breast-feeding (women of child-bearing potential)
• Prior severe allergic drug reactions
• Prior history of cancer in the last 5 years prior to enrollment, other than curatively treated cancer of the cervix or non-melanoma skin cancer.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Innogene Kalbiotech Pte. Ltd: collaborator

Study Sites (1)

National Cancer Center Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

nimotuzumab; Cisplatin; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Study Officials

• Wan-Teck Lim, MD

  National Cancer Center Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: April 28, 2008
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

SG (1)